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Quality Engineer
Job
Astrix Technology Group
Irvine, CA (In Person)
Full-Time
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Job Description
Quality Engineer Astrix Technology Group - 3.4 Irvine, CA Job Details 1 hour ago Qualifications Defect resolution root cause analysis ISO standards Project management in manufacturing Quality risk management Regulatory/legal compliance standards in production Biomedical regulatory compliance Technical troubleshooting support FDA regulations Failure analysis Full Job Description Our client, a growing leader in the medical device industry, is seeking a Quality Engineer to play a critical role in ensuring product quality, manufacturing excellence, and regulatory compliance throughout the product lifecycle. This is an opportunity to work on impactful medical technologies while partnering with cross-functional teams to drive continuous improvement, solve complex technical challenges, and enhance patient outcomes. What You'll Do Lead investigations into manufacturing and customer-reported quality issues, identifying root causes and implementing effective corrective and preventive actions (CAPA). Develop and execute quality control strategies that support manufacturing continuity and ensure product compliance with established specifications and regulatory requirements. Analyze product performance data using statistical and risk-based methodologies to identify trends, assess risk, and support data-driven decision-making. Perform hands-on troubleshooting of returned products and manufacturing nonconformances while documenting findings and recommendations. Partner with Engineering, Manufacturing, Regulatory Affairs, and other cross-functional teams to resolve quality concerns and support business objectives. Communicate complex technical issues and solutions to both technical and non-technical stakeholders. Support continuous improvement initiatives and quality-focused projects across the organization. Ensure compliance with Quality System requirements and applicable regulations, including FDA and ISO standards governing medical devices. What We're Looking For Bachelor's degree in Engineering required. Minimum of 3 years of experience in a regulated industry, preferably within medical device manufacturing or a related manufacturing environment. Strong understanding of quality systems, root cause analysis, risk management, and data analysis methodologies. Knowledge of FDA regulations, including 21 CFR Part 820 and Part 803. Familiarity with ISO 13485 and medical device quality management systems. Proven ability to manage multiple priorities, lead investigations, and drive resolution of complex quality issues. Strong communication and project management skills. INDBH LI-BH1